InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-O )

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Brief Title

InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )

Official Title

A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Oncology Cohort

Brief Summary

      Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for
      three weeks on immune reconstitution of lymphopenic COVID-19 patients
    

Detailed Description

      Approximately forty-eight (48) participants will be randomized 1:1 to receive

      (a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of
      observation, by 10 μg/kg twice a week for 3 weeks (maximum 7 administrations adjusted to
      patient's length of stay in the hospital) or (b) Intramuscular (IM) placebo (normal saline)
      at the same frequency.

      The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of
      these patients and observe possible association with a clinical improvement.

      This cohort is dedicated to oncology patients
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first

Secondary Outcome

 "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD.

Condition

COVID-19

Intervention

CYT107

Study Arms / Comparison Groups

 CYT107 Treatment
Description:  Intramuscular (IM) administration of CYT107 twice a week for 3 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

48

Start Date

December 20, 2020

Completion Date

December 31, 2021

Primary Completion Date

December 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. A written, signed informed consent, or emergency oral consent, by the patient or the
             patient's legally authorized representative, and the anticipated ability for
             participant to be re-consented in the future for ongoing Study participation

          2. Patient receiving active or recent chemotherapy or immunotherapy (within 6 months) for
             cancer (and/or)

          3. Patients who have received hematopoietic stem cell transplantation (for a diagnosis
             other than lymphoma) within the past 1 year (and/or)

          4. Patients who received CAR-T cell therapy within the past 1 year (but not within last
             30 days- see also exclusion criteria number 6 & 7) (and/or)

          5. Patients receiving hormonal therapy for cancer (and/or)

          6. Patients who have undergone surgery or radiotherapy for cancer within the past 6
             months

          7. Patients with newly diagnosed (biopsy proven) malignancy who have not yet received
             cancer treatment but get COVID pneumonia in the interim (Incl. Criteria 11)

          8. Men and women aged ≥ 25 - 80 (included) years of age

          9. Hospitalized patients with one absolute lymphocyte count (ALC) ≤ 1000 cells/mm3,
             collected at baseline or no more than 72h before baseline .

             From this time point the investigator may choose to further postpone the commencement
             of IL-7 (CYT107) treatment according to patient's clinical status.

         10. Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at
             >4L per minute nasal cannula or greater to keep saturations >90%, non-invasive
             positive pressure ventilation (e.g., BIPAP), or patients intubated/ventilated for
             respiratory failure

         11. Confirmed infection with COVID-19 by any acceptable test available/utilized at each
             site

         12. Willingness and ability to practice contraception regardless of the gender of the
             patient during 5 months after last drug exposure

        Exclusion Criteria:

          1. Pregnancy or breast feeding;

          2. ALT and/or AST > 5 x ULN

          3. Known, active auto-immune disease;

          4. Patients with a history of lymphoid malignancy

          5. Patients with any malignancy that is present at time of enrollment where treating
             physician expects life expectancy due to the underlying malignancy to be less than 6
             months

          6. Patients who received CAR-T cell therapy within the past 30 days or with unresolved
             cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity
             syndrome (ICANS)

          7. Patients with unresolved grade > 2 toxicities from prior chemotherapy, immunotherapy,
             or CAR-T cell therapy

          8. Patients with past history of Solid Organ transplant.

          9. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral
             load.

         10. Hospitalized patients with refractory hypoxia, defined as inability to maintain
             saturation >85% with maximal available therapy for >6 hours

         11. Patients with a mechanical ventilation support ≥ 7 days

         12. Patients with chronic kidney dialysis

         13. Patients with a SOFA score ≥ 9 at baseline

         14. Patients with a BMI > 40

         15. Patients showing an increase of the NEWS2 score by more than 6 points during the
             screening/ baseline period (48 to 72 hrs prior to first administration)

         16. Patients with hospital admission Rockwood Clinical Frailty Scale ≥ 6. (assessed as
             patient or proxy 4-week recall of chronic health and frailty status prior to COVID
             infection)

        11. Patients under guardianship
      

Gender

All

Ages

25 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Steve Pastores, MD, +33603357060, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04426201

Organization ID

ILIAD-7 COVID US ONCO


Responsible Party

Sponsor

Study Sponsor

Revimmune

Collaborators

 Memorial Sloan Kettering Cancer Center

Study Sponsor

Steve Pastores, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

February 2021